General Scope and Summary
This newly created position is responsible for leading the lifecycle management of electronic clinical systems, including eTMF and CTMS. The Manager of IT Clinical Systems will serve as an expert technical resource, collaborating with Clinical Operations and Quality Systems in the selection, implementation, configuration, and maintenance of applications.
Roles and Responsibilities:
- Partner with stakeholders throughout full lifecycle of clinical systems integration – from defining business need, project planning, vendor selection, development, deployment, and end user adoption – and provide ongoing management and functional oversight for all electronic clinical systems.
- Partner with external service providers.
- Serve as the system administrator (owner) of the eTMF and CTMS platform.
- Consult with Clinical Operations to evaluate and outline the evolving data storage and reporting needs.
- Create and maintain the eTMF Operating Model to include standards and best practices aligned across multiple programs and organizational goals.
- Liaise with external vendors to define data exchange processes.
- Oversee the transfer and incorporation of clinical trial operational data into the CTMS.
- Analyze business processes, propose solutions for current and future needs, and assist in implementing recommended improvements, in accordance with Sage operating standards.
- Assure system is properly implemented according to business requirements and FDA Part 11 requirements. Ensure systems maintain GxP validated state, including preparation of documentation, execution of testing, management of user access, and coordinating change management and related processes.
- Develop and manage system documentation including, but not limited to, user requirement specifications, configuration specifications, user acceptance testing plans, SOPs, and validation records.
- Collaborate with users to establish operational workflows and transform the workflows into system configuration.
- Work with functional leaders to align on key measures and metrics for success.
- Oversee the creation and customization of program- and department-level analytical reports and dashboards to support a data-driven operating model.
- Lead ad-hoc analytical projects.
- Develop and maintain internal data repositories, as needed.
- Drive innovation and the delivery of continuous process improvement.
- Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient. Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations. Demonstrated ability to translate strategy into action; excellent analytical skills and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks.
Experience, Education and Specialized Knowledge and Skills:
- Bachelor’s degree required (scientific or technical discipline), post-graduate degree preferred.
- 5 years of experience working in the clinical environment managing clinical systems (for example, EDC, IRT, eTMF, CTMS, clinical data warehouses), underlying processes, and data.
- 5 years of experience in pharmaceutical/biotechnology and extensive knowledge of ICH-GCP guidelines, 21 CRF Part 11, and major Health Authority regulations as they pertain to the operational aspects of clinical studies and the management of TMF content and TMF reference model.
- Experience with Veeva Vault and Veeva Vault configuration.
- Veeva Certified Administrator a plus
- Proactive and positive management approach.
- Experience in developing business specifications/requirements and user acceptance testing for computer systems.
- Experience with vendor management and oversight of data exchange, migration and integration.
- Demonstrated ability to analyze complex issues, to develop relevant and realistic recommendations and plans, and to drive projects to consistently meet deadlines.
- Excellent planning, organizational and time management skills, including the ability to support and prioritize multiple projects, both working independently and within a team.
- Flexibility to adapt to the dynamic needs of a growing biotech company and to manage change effectively.
- Ability to learn quickly and adjust approach to problems based on feedback.
- Demonstrated experience working in a matrix environment.
- Strong team player that has a customer service approach and is solution oriented.
- PC literacy required, including fluid use of common MS applications.
- Embrace our core values: Put People First, Do Big, Be Accountable, Grow through Learning and Change, and Work Fun.
- Excitement about the vision and mission of SAGE.